Institute for Resources, Environment and Sustainability, University of British Columbia, Aquatic Ecosystem Research Laboratory, 4th Floor, 2202 Main Mall, Vancouver, British Columbia, Canada.
Environ Sci Technol. 2013 Jun 4;47(11):5524-34. doi: 10.1021/es303591x. Epub 2013 May 24.
Engineered nanomaterials (ENMs) promise great benefits for society, yet our knowledge of potential risks and best practices for regulation are still in their infancy. Toward the end of better practices, this paper analyzes U.S. federal environmental, health, and safety (EHS) regulations using a life cycle framework. It evaluates their adequacy as applied to ENMs to identify gaps through which emerging nanomaterials may escape regulation from initial production to end-of-life. High scientific uncertainty, a lack of EHS and product data, inappropriately designed exemptions and thresholds, and limited agency resources are a challenge to both the applicability and adequacy of current regulations. The result is that some forms of engineered nanomaterials may escape federal oversight and rigorous risk review at one or more stages along their life cycle, with the largest gaps occurring at the postmarket stages, and at points of ENM release to the environment. Oversight can be improved through pending regulatory reforms, increased research and development for the monitoring, control, and analysis of environmental and end-of-life releases, introduction of periodic re-evaluation of ENM risks, and fostering a "bottom-up" stewardship approach to the responsible management of risks from engineered nanomaterials.
工程纳米材料（ENMs）有望为社会带来巨大利益，但我们对潜在风险的了解以及监管的最佳实践仍处于起步阶段。为了更好地实践，本文使用生命周期框架分析了美国联邦环境、健康和安全（EHS）法规。它评估了它们在适用于 ENMs 方面的充分性，以确定新兴纳米材料可能逃避从初始生产到生命周期结束的监管的差距。科学不确定性高、缺乏 EHS 和产品数据、设计不当的豁免和阈值以及机构资源有限，这对现行法规的适用性和充分性都是一个挑战。其结果是，某些形式的工程纳米材料可能会在其生命周期的一个或多个阶段逃避联邦监督和严格的风险审查，最大的差距出现在后期市场阶段，以及工程纳米材料向环境释放的点。通过即将进行的监管改革、加强对环境和生命周期结束时释放的监测、控制和分析的研究和开发、定期重新评估 ENM 风险以及培养一种自下而上的管理工程纳米材料风险的责任方法，可以改善监督。
